CAT #: A4120071
FLT3 ITD MM - 6FAM & HEX- ASR
Master mixes are components of complete assays. Master mixes are composed of a buffered magnesium solution, deoxynucleotides, and multiple primers that target the gene segments of interest. These Master Mixes do not include Taq DNA Polymerase.
FLT3 ITD or length mutations are caused by duplication and insertion of a portion of the FLT3 gene that includes the region in and around the juxtamembrane (JM) region. This product targets this region of the FLT3 gene.
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Analyte Specific Reagents (ASRs) may only be sold to:
- in vitro diagnostic manufacturers;
- clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing, or clinical laboratories regulated under VHA Directive 1106; and
- organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research and other nonclinical laboratories. 21 CFR 809.30 (b).
Analyte Specific Reagent; Analytical and performance characteristics are not established.
Ordering Requirements: Prior to ordering any ASR product, each customer facility must verify that they are a CLIA certified high-complexity laboratory.